Status:
COMPLETED
A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Preventing SARS-CoV-2 Infection and COVID-19 in Nursing Home Residents and Staff
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
AbCellera Biologics Inc.
Conditions:
COVID-19
SARS-CoV2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate whether LY3819253 given alone and with LY3832479 prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and coronavirus disease - 2019 ...
Eligibility Criteria
Inclusion
- Part 1 and Part 2: Resident or facility staff in a skilled nursing or assisted living facility with at least one confirmed case of SARS-CoV-2 detection less than or equal to (≤)7 days prior to randomization
- Are men or non-pregnant women who agree to contraceptive requirements
- Agree to the collection of nasal, mid-turbinate, oropharyngeal, and nasopharyngeal swabs, and venous blood as specified in the schedule of activities
- Have venous access sufficient to allow intravenous infusions and blood sampling
- The participant or legally authorized representative give signed informed consent
- Part 3 only: Resident or staff in a skilled nursing or assisted living facility who satisfy at least one of the following at the time of screening
- Are greater than or equal to (≥) 65 years of age
- Have a body mass index (BMI) ≥ 35
- Have chronic kidney disease
- Have type 1 or type 2 diabetes
- Have immunosuppressive disease
- Are currently receiving immunosuppressive treatment, or
- Are ≥ 55 years of age AND have
- cardiovascular disease, OR
- hypertension, OR
- chronic obstructive pulmonary disease or other chronic respiratory disease
- Positive SARS-CoV-2 test and infusion within 10 days of symptom onset, OR positive SARS-CoV-2 test and infusion within 10 days of testing if asymptomatic
Exclusion
- Parts 1 and 2:
- Recovered from confirmed COVID-19 disease or asymptomatic infection
- Prior history of a positive SARS-CoV-2 serology test
- History of convalescent COVID-19 plasma treatment
- Participation in a previous SARS-CoV-2 vaccine trial or received an approved SARS-CoV-2 vaccine
- Previous receipt of SAR-CoV-2-specific monoclonal antibodies
- Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study
Key Trial Info
Start Date :
August 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2021
Estimated Enrollment :
1180 Patients enrolled
Trial Details
Trial ID
NCT04497987
Start Date
August 2 2020
End Date
May 20 2021
Last Update
February 4 2022
Active Locations (27)
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1
Unv of AL Sch of Med Div of Infectious Diseases
Birmingham, Alabama, United States, 35294
2
Care Access Research
Phoenix, Arizona, United States, 85023
3
Allergy and Asthma Clin of NW Ark
Bentonville, Arkansas, United States, 72712
4
Care Access Research LLC
Huntington Beach, California, United States, 92648